Unistik 3 AT 1044Recalls & reported problems
Owen Mumford Limited · Unistik 3 Comfort 28G x 1.8mm, 200 count - sterile, single use safety lancet · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384701044014), received between Jun 23, 2023 and Jun 23, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Retraction Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Retraction Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2023Retraction Problem; Retraction Problem
NURSE WAS TAKIN A GLUCOSE CHECK ON A PATIENT USING THE UNISTIK LANCET. THE NURSE PLACED THE LANCET ON THE BED TO USE THE SCANNER TO CHECK THE GLUCOSE. WHEN SHE PICKED UP THE LANCET FROM THE BED, SHE FELT A POKE IN HER FINGER. ON THE OUTSIDE OF HER GLOVE WHERE THE POKE WAS FELT, SHE NOTICED THERE WAS SOME BLOOD. THE LANCET IN QUESTION WAS DISPOSED OF IN THE HSARPS CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17192297 ↗InjuryJun 23, 2023Retraction Problem; Retraction Problem
NURSE WAS TAKING A GLUCOSE CHECK ON A PATIENT USING THE UNISTIK LANCET. THE NURSE PLACED THE LANCET ON THE BED TO USE THE SCANNER TO CHECK THE GLUCOSE. WHEN SHE PICKED UP THE LANCET FROM THE BED, SHE FELT A POKE IN HER FINGER. ON THE OUTSIDE OF HER GLOVE WHERE THE POKE WAS FELT, SHE NOTICED THERE WAS SOME BLOOD. THE LANCET IN QUESTION WAS DISPOSED OF IN THE SHARPS CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17192291 ↗
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- BD Microtainer® Contact-Activated Lancet 366592Becton, Dickinson And Company · Single use only blood lancet with an integral sharps injury prevention feature14 reports
- Medline MPHSFTY28Medline Industries, Inc. · Single use only blood lancet with an integral sharps injury prevention feature6 reports
- Unistik Touch AT 1444Owen Mumford Limited · Lancet, Blood4 reports
- Unistik 3 AT 1012Owen Mumford Limited · Lancet, Blood3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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